A comparative study to evaluate the efficacy and safety of twice daily versus alternate day oral iron therapy in treatment of mild to moderate iron deficiency anemia in adults - an open label, randomized controlled study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Efficacy is assessed by increase in mean Hemoglobin and serum ferritin levels at the end of 4th week and 8th weeks respectively.
研究概览
简要总结
Iron deficiency anemia (IDA) remains a major public health concern, with oral iron therapy being the primary treatment. However, gastrointestinal side effects and poor absorption often lead to non-adherence. Recent evidence suggests that alternate-day iron dosing may enhance iron absorption while reducing side effects. This study aimed to compare the efficacy and safety of twice-daily versus alternate-day oral ferrous sulfate therapy in adults with mild to moderate IDA.
The study was conducted in the General Medicine OPD of a tertiary care hospital from May 2023 to October 2024. A total of 100 patients diagnosed with IDA were randomly assigned into two groups in a 1:1 ratio:
- Group A: Received Ferrous sulfate 200 mg twice daily for 8 weeks.
- Group B: Received Ferrous sulfate 400 mg once on alternate days for 8 weeks. Hemoglobin (Hb) and serum ferritin levels, as well as adverse effects, were assessed at baseline, 4 weeks, and 8 weeks.
There was a significant increase in Hb (p<0.001) and ferritin (p<0.001) in both groups. Additionally, a statistically significant interaction between time and groups for Hb (p=0.04) and ferritin (p=0.001) was seen. At 8 weeks, Hb increased by 2.52 g/dL in the twice-daily group and 1.91 g/dL in the alternate-day group. Serum ferritin increased by 29.92 µg/L and 23.41 µg/L, respectively.
Adverse effects were mostly mild, with nausea and upper gastric discomfort being the most common. Overall, twice-daily and alternate-day iron therapy are both effective in IDA treatment. While twice-daily dosing leads to a greater Hb and ferritin rise, the alternate-day regimen is better tolerated, making it a preferred option for patients with gastrointestinal intolerance
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient willing to give written informed consent and willing to come for follow-up
- •Adults 18-60 years of age of either sex
- •Patients newly diagnosed as mild to moderate iron deficiency anemia by WHO guidelines.
排除标准
- •Patients having comorbidities like chronic kidney disease, chronic liver disease, severe anemia requiring blood transfusion/parenteral iron therapy, cardiac failure patients, gastrointestinal abnormalities, menstrual abnormalities, malignancies and HIV
- •Pregnant and Lactating mothers
- •Patients with clinical or laboratory evidence of other causes of anemia like hemolytic anemias, hemoglobinopathies, gastrointestinal bleed, iron malabsorption, megaloblastic anemia, or anemia of chronic disease
- •Patients with hypersensitivity and intolerance to oral iron supplements.
结局指标
主要结局
Efficacy is assessed by increase in mean Hemoglobin and serum ferritin levels at the end of 4th week and 8th weeks respectively.
时间窗: 0,4,8 weeks
次要结局
- Safety is assessed by monitoring and recording adverse events reported by the patient at any time of the study.
研究者
Geetha A
Bangalore Medical College and Research Institute